Bi-directional dampening and assisting unit

ABSTRACT

A dynamic platform with extending struts has fastened thereto a bi-directional torsional power unit to selectively deliver force opposing either extension or flexion, and to provide assistance in a respective opposite direction. The power unit is threadably mounted on a hinge pin (spline) centrally located on the platform, and is latched to a catch assembly radially located thereto, the hinge pin of the platform communicating with one end of a torsion spring of the power unit and the catch assembly communicating with another end of the torsion spring, to selectively deliver the extension/flexion force. The power unit can be detached, with simple manual operation of the catch assembly, without tools, flipped over and reattached to the same platform attachment points to switch (reverse) extension torque to flexion torque and vice versa.

RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.14/249,511, filed Apr. 10, 2014 (now U.S. Pat. No. 9,377,079); whichapplication claims benefit of priority of U.S. Provisional ApplicationNo. 61/810,412, filed Apr. 10, 2013. Each of the above-identifiedrelated applications are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to hinge or joint devicesgenerally, and more particularly to a hinge or joint assembly, at theankle, wrist, knee or ankle, adapted to exert a bi-directional force atthe body joint to provide dynamic shock absorption and returnassistance, while enabling normal, or close to normal, ambulatorymotion.

BACKGROUND OF THE INVENTION

To treat flexion and extension contractures, spring-biased splint unitshave been developed to provide a force across a body joint. These splintdevices provide tension that operates in opposition to a flexion orextension contracture and thereby not only provide support in instanceswhere muscular weakness exists, but also enhance rehabilitation.Generally, treatment involves lengthening short muscles and reducingsoft tissue contracture caused by various pathologies that result injoint movement limitations. In one example, two struts are pivotallyinterconnected, and include a spring bias unit therebetween to apply anadjustable force at the pivot point of the interconnected struts.

For helpful background information, U.S. Pat. No. 5,658,241 to DeHardeincludes a prior teaching, generally, of torsional power units,multi-functional dynamic splints, spring bias adjustment mechanisms,range of motion limiters, and early bi-directional functionality.DeHarde, U.S. Pat. No. 5,658,241, is incorporated herein by referencefor its helpful detailed description of the various assembly components,their interaction and functionality, all providing a better appreciationand background for the present invention. More particularly, U.S. Pat.No. 5,658,241, teaches a dynamic splint using a bi-directional torsionalpower unit fastened between first and second struts to selectivelydeliver force opposing either extension or flexion. In U.S. Pat. No.5,658,241, the power unit is mounted about a hinge pin and can berotated about the hinge pin between two positions. In a first position,the power unit is locked relative to the first strut and the torsionspring opposes relative movement of the second strut in a firstdirection. Rotated about the hinge pin to a second position, the powerunit is locked relative to the second strut. In this second position,the torsion spring opposes movement of the first strut relative to thesecond strut, providing torsion in an opposite direction from that ofthe first position.

SUMMARY OF THE INVENTION

The present invention is a hinge assembly providing a dynamic, universalplatform, with struts extending therefrom, having attached thereto abi-directional, torsional power unit to selectively deliver forceopposing either extension or flexion. The power unit includes a torsionspring, such as a circular leaf spring. In the present invention, thepower unit can be easily reversed to provide a flexion or extensionforce for any human joint by simply flipping the power unit over andsnapping the power unit back into place on the platform. The power unitis mounted on a hinge pin (spline) of the platform, and also attaches toa tab, pin or latch communicating with one of the struts.

The present invention hinge assembly (combination dynamic platform andpower unit) provides a slimmer, lighter, lower profile design withincreased functionality and more adaptable torque characteristics. Thepresent invention could, for example, be a hinge assembly for anorthotic, prosthetic or rehabilitative device; or generally be a hingedsplint type device for applying force across a body joint.

Further, the present invention provides a platform having unique wormgear range of motion (ROM) limiters able to infinitely limit any angularjoint displacement required to either correspond to or exceed thedesired body joint motion. The worm gear ROM limiters can work inconjunction with hard stops placed in arcuate slot. In variousembodiments, one or two worm gears might be employed on the platform tolimit range of motion. In any embodiment, the platform of the presentinvention can be easily set for an elbow, knee, ankle or wrist humanjoint. In view thereof, any limit on the range of motion (within thetypical range of motion for the respective body joint) can be set, inboth directions—extension or flexion. Further, the platform can providea locking feature for any 7.5 degree of motion, or any 15 degree ofmotion, and also provide a free motion option for ease of donning anddoffing of the associated brace. In another aspect of the invention, twoplatform sizes (and two power unit sizes) can facilitate any human bodyjoint, a complete range of motion thereof, and various torqueresistances/assistances.

As mentioned above, reversing extension torque into flexion torque canbe accomplished by flipping the power unit over. The spline interfacebetween the platform and the power unit permits a user to match therange of motion needed for the desired body joint to that possible bythe present invention. Accordingly, the desired range of motion of thebody joint can be matched to the total spring deflection possible forthe power unit to yield a torque over that same range of motion toeither provide a desired flexion or extension force. The spline of theplatform transmits torque from the power unit to rotate the platform(i.e., to angularly move the struts relative to one another) and theassociated brace attached thereto to yield a desired clinical benefit.

In one aspect of the present invention, the power unit allows for 150degrees of torque resist/assist and the spline orients this torqueresist/assist range of motion to the desired range of the platform. Eachspline tooth can shift the range of motion 15 degrees to enable thisadvantageous feature. The spline connection (i.e., power unit mounted onthe spline of the platform) could be used to transmit any force creatingmechanism (i.e., power unit) to a joint (i.e., platform) having a strutarrangement to control, assist or dampen the struts, and thereforecontrol, assist or dampen any movement of the respective body joint.

In one general embodiment of the present invention, a hinge assemblyincludes a first strut and a second strut pivotally attached to oneanother at a pivot point. A spline generally extends in a firstdirection perpendicularly through the first strut and the second strutand serves as the pivot point. The spline can be rotatably fixedrelative to one of the first strut and the second strut, the other ofthe first strut and the second strut has a single catch extending in thefirst direction, located radially of the pivot point. Also included is atorsion spring having a first end and a second end, where the first endof the torsion spring is removably attached to the extending spline andthe second end of the torsion spring is removably attached to the singleextending catch.

The torsion spring applies a bias force opposing relative pivotalmovement between the first and the second struts in a first of twoopposite directions, and aids pivotal movement in a second of theopposite directions. The torsion spring can be detached from theextending spline and the single extending catch, turned over, andre-attached. Re-attachment involves again connecting the first end ofthe torsion spring to the extending spline and the second end of thetorsion spring to the single extending catch. A bias force opposingrelative pivotal movement between the first and the second struts in thesecond of the opposite directions is then applied, along with assistanceof pivotal movement in the first of the opposite directions.

The hinge assembly can also include a toothed tension wheel mountedabout the pivot point and rotatably fixed relative to the spline, and anaxially rotatable, but otherwise fixed, worm gear located about aperimeter of the tension wheel, the worm gear threadably communicatingwith the tension wheel to preload the torsion spring.

In another embodiment of the present invention, the hinged device usedto apply force across a body joint includes a platform having a firststrut, a second strut; and a joint assembly having a threaded spline ata pivot point thereof. The threaded spline is workably fixed to one ofthe first strut or the second strut—the other of the first strut or thesecond strut has a catch located radially of the pivot point, the firststrut and the second strut pivoting relative to one another about thepivot point.

The hinged device also includes a power unit having a torsion spring,and a housing having an internally threaded reception slot centrallylocated on each of opposing housing sides of the power unit. Thereception slot is workably attached to a first end of the torsionspring. The housing also has a catch receiver similarly located on eachof opposing housing sides of the power unit, the catch receiver beingworkably attached to a second end of the torsion spring.

In this embodiment, when a first housing side is exposed away from andopposite the platform, the power unit attaches to the platform to applya bias force opposing relative pivotal movement between the first andthe second struts in a first of two opposite directions, and aidingpivotal movement in a second of the opposite directions. When a secondhousing side is exposed away from and opposite the platform, the powerunit attaches to the platform to apply a bias force opposing relativepivotal movement between the first and the second struts in the secondof the opposite directions, and aiding pivotal movement in the first ofthe opposite directions.

The power unit can be detached, flipped over and reattached to theplatform (reversed), without the use of tools. The power unit is flippedover from the first housing side being exposed away from and oppositethe platform to the second housing side being exposed away from andopposite the platform. Reversing the power unit on the platform isaccomplished without taking apart a spring housing, or requiringdismantling of a spring device. Nor does reversing the power unit on theplatform (reversing the direction of force) require use of a differentspring(s), or the re-installation of the spring in different holes or atdifferent contact points (points of attachment) on the platform.

In the present invention, points of attachment between the power unitand the platform can consist only of the one centrally located receptionslot on each housing side of the power unit, the one spline of theplatform, the one catch receiver similarly axially located on eachhousing side of the power unit, and the one catch on the platformlocated radially of the pivot point.

In another aspect, the hinged device of the present invention can alsoinclude an axially translatable handle that toothedly engages a gearcentered about the pivot point to arrest pivotal movement of the firststrut relative to the second strut. The power unit could also include anexternally threaded spring band located about a perimeter of the torsionspring, centered about the pivot point, and workably attached to thesecond end of the torsion spring, and an axially rotatable, butotherwise fixed, preload worm gear located about a perimeter of thespring band, the preload worm gear threadably communicating with thespring band to preload the torsion spring. The torsion spring, springband and the worm gear could be positioned in the same plane.

The catch of the present invention device could extend perpendicularlyfrom the respective strut, and include at a distal end thereof a lipextending perpendicularly toward the pivot point, the catch being springbiased toward the pivot point and linearly translatable along alongitudinal axis of the respective strut. The catch receiver could bean aperture similarly and opposingly located on each housing side of thepower unit. The spring biased catch could cause a snap connection of thelip to the aperture when the power unit is attached to the platform. Ifalso including the axially translatable handle, the catch could extendperpendicularly from the respective strut from within, and be surroundedby, the axially translatable handle.

In another aspect, the present invention platform might further have atoothed range of motion (ROM) wheel mounted about the pivot point androtatable relative to the first and the second struts; and an axiallyrotatable, but otherwise fixed, ROM worm gear located about a perimeterof the ROM wheel. The ROM worm gear threadably communicates with the ROMwheel to adjust a range of motion of the first strut relative to thesecond strut.

The joint assembly of the present invention might also include at leastone end range tapped hole rotatably fixed relative to one of the firstand the second struts, at least one end range screw, inserted into andextending from the at least one end range tapped hole, and an arcuateslot rotatably fixed relative to the other of first and the secondstruts. The at least one end range screw extends into the arcuate slotto limit range of motion the device. Here, the platform provides up to a150° range of motion of the first and the second struts.

In this joint assembly embodiment, a position of the at least one endrange tapped hole, with the at least one end range screw insertedtherein, allows motion of the at least one end range screw within thearcuate slot from 135° of flexion to 15° of hyperextension. Thisprovides a correct anatomical range of motion for a knee. At least asecond end range tapped hole could also be included, each end rangetapped hole having a position, where, with end range screws insertedtherein, allows motion of the end range screws within the arcuate slotof 75° of plantar flexion to 75° of dorsiflexion to provide a correctanatomical range of motion for a wrist or ankle. The joint assemblymight also include the toothed range of motion (ROM) wheel and ROM wormgear, detailed above, to adjust a range of motion of the first strutrelative to the second strut within the fixed limits established by theat least one end range tapped hole, the at least one end range screw,and the arcuate slot.

The ROM wheel could also include at least two stop angle marks on aperimeter thereof, one mark corresponding to an extension range limitand another mark corresponding to a flexion range limit. Here, the ROMworm gear is used to rotatably position one of the stop angle marks atan angle relative to a midline of the first strut to finely adjustdevice range of motion, wherein platform angular motion is limited tothe angle in a respective flexion or extension range. In thisembodiment, the ROM worm gear can function to finely adjust device rangeof motion with the power unit attached to or detached from the platform.

Also included in the present invention is a method of reversing anangular direction of force applied by and above detailed hinge assemblyembodiment, the method including the steps of linearly translating thecatch along a longitudinal axis of the other of the first strut or thesecond strut, away from the pivot point and against the spring bias ofthe catch; pulling the power unit in a direction perpendicular of thefirst and the second struts, lifting the power unit off of the spline todetach the power unit from the platform; turning (flipping) the powerunit over; threadably engaging the reception slot of the housing withthe spline while aligning the catch receiver of the housing with thecatch, without the use of tools, and without requiring use of any otherpoint of attachment on or between either the platform or the power unit;and pressing the power unit against the platform until the spring biasedcatch causes snap connection of the catch to the catch receiver. Theabove steps attach the power unit to the platform to apply a bias forceopposing relative pivotal movement between the first and the secondstruts in a direction opposite that of the force applied prior toturning (flipping) the power unit over, and aiding pivotal movement in adirection opposite of that provided prior to turning the power unitover.

BRIEF DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The present invention will be better understood with reference to thefollowing description taken in combination with the drawings. For thepurpose of illustration, there are shown in the drawings certainembodiments of the present invention. In the drawings, like numeralsindicate like elements throughout. It should be understood, however,that the invention is not limited to the precise arrangements,dimensions, and instruments shown:

FIG. 1 illustrates a bi-directional dampening/assisting unit accordingto one embodiment of the present invention, including power unitattached to a platform, where the power unit provides extension orflexion torque upon respective angular movement of struts extending fromthe platform, and where the power unit can be flipped over to switchfrom extension torque to flexion torque, or vice versa, in therespective angular direction;

FIG. 2a illustrates a platform according to an embodiment of the presentinvention that includes two struts interconnected at a pivot point, withthreaded spline extending therefrom, where the struts are located in oneworking position; FIG. 2b illustrates the platform of FIG. 2a , wherethe struts are located in another working position;

FIG. 3 illustrates the platform of FIGS. 2a and 2b in exploded view;

FIG. 4 illustrates a bi-directional dampening/assisting unit accordingto another embodiment of the present invention, again including powerunit attached to a platform of the present invention, where the powerunit provides extension or flexion torque upon respective angularmovement of struts extending from the platform, and where the power unitcan be flipped over to switch from extension torque to flexion torque,or vice versa, in the respective angular direction;

FIG. 5 illustrates a side view of the bi-directional dampening/assistingunit of FIG. 4, with power unit attached to the platform; and

FIG. 6 illustrates the power unit of FIGS. 4 and 5 in exploded view;

FIGS. 7a, 7b and 7c illustrate a front, side and exploded view,respectively, of another embodiment of the platform 10 of the presentinvention (i.e., the platform 10 shown in FIG. 1);

FIGS. 8a, 8b, 8c, 8d and 8e illustrate perspective, top side, edge,opposite side and exploded views, respectively, of another embodiment ofthe power unit 100 of the present invention (i.e., the power unit 100shown in FIG. 1);

FIGS. 9a, 9a ′ and 9 b illustrate a front profile, a side profile and areverse profile of the platform 10 embodiment of FIGS. 1, 7 a, 7 b, and7 c;

FIGS. 10a and 10b illustrate a front profile and a reverse profile ofthe power unit 100 embodiment of FIGS. 1, 8 a, 8 b, 8 c, 8 d and 8 e;

FIGS. 11a, 11b and 11c illustrate fine tuning of the platform 10embodiment of FIGS. 1, 7 a, 7 b, 7 c, 9 a, 9 a′ and 9 b, to blockexcessive or unwanted flexion or extension range of motion; and

FIGS. 12a, 12b, 12c, 12d and 12e illustrate how to use thebi-directional dampening/assisting unit of FIG. 1; more specifically,how to set up the platform 10 and attach the power unit 100 thereto forcertain flexion/extension assist.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The present invention provides a dynamic platform, having strutsextending therefrom, and having fastened thereto a bi-directionaltorsional power unit, between first and second struts. The torsionalpower unit selectively delivers force opposing either extension orflexion, while providing assistance in a respective opposite direction.The torsional power unit is mounted on a hinge pin (spline) extendingfrom a pivot point of the platform, where the power unit can be flippedover to switch (reverse) the force opposing extension or flexion to therespective other thereof.

FIG. 1 illustrates a bi-directional dampening/assisting unit 5 accordingto one embodiment of the present invention, including power unit 100 andplatform 10. FIGS. 2-3 illustrate a platform 10 of the present inventionincluding a first and a second strut 12, 14 interconnected at a pivotpoint 16, with threaded spline 18 extending therefrom, FIG. 3illustrating an exploded view. The threaded spline 18 is rotationallyfixed in relation to the second strut 14. The pivot point and componentsof the platform other than the struts 12, 14 form a joint assembly.

FIG. 2a illustrates the platform 10 in one working position, aligned foruse (range of motion (ROM) appropriate for) a knee or elbow joint.Alignment of the platform 10 is shown by graduated markings 20 posted ona side of the platform 10. Alignment of the platform is performed bymanual operation of a toothed disk 22, associated and aligned with thefirst strut 12, to linearly translate the toothed disk 22 in relation tothe first strut 12 to engage a stationary and toothed alignment wheel24. FIG. 2b illustrates the platform in another working position,aligned for use (range of motion appropriate for) an ankle or wrist. Inone embodiment, each graduated marking represents 15 degrees, which isequal to the degree range associated with each thread of the spline 18.

Alignment is shown by a tab or pin 26. The tab 26 is fixed in relationto, and extends at a relative distal end location of, the first strut12. Accordingly, the first strut 12 and the second strut 14 communicatewith the joint assembly, providing that the first strut 12 can pivotallymove relative to the second strut 14 about the pivot point 16.

Referring now to FIG. 3, the platform 10 further includes a stationaryand toothed range of motion (ROM) wheel 28. Two worm gears 30, 32, eachcommunicating with, and movable in relation to, a perimeter of the ROMwheel 28, provide range of motion stops (or limiters) for the platform10. Accordingly, the pivotal range of motion of one strut (e.g., thefirst strut 12) relative to the other strut (e.g., the second strut 14)is limited by a relative position of each worm gear 30, 32, acting as astrut stop, about the perimeter of the ROM wheel 28. Axial rotation ofeach worm gear 30, 32, respectively indexes (translates) the respectiveworm gear about the perimeter of the stationary ROM wheel 28.

FIGS. 4-6 illustrate a power unit 100 of the present invention attachedto a platform 10 of the present invention, whereby the power unit 100provides extension or flexion torque upon respective angular movement ofthe struts 12, 14. FIG. 6 illustrates an exploded view. The power unit100 can be flipped over on the platform 10 to switch from extensiontorque to flexion torque, or vice versa, in a respective direction.

The power unit 100 includes a torsion spring 102 (e.g., a circular leafspring) and a internally threaded reception slot 104 open to, andcentrally located on, each of opposing sides of the power unit 100(i.e., open to, and centrally located within, each of opposing housingside plates 106, 108). The respective reception slot 104 communicateswith a first end 110 of the torsion spring 102.

The power unit 100 threadably attaches to the platform 10 via the spline18 and the reception slot 104 open on a first side housing plate 108 ofthe power unit 100 (as shown in FIGS. 4 and 5) to apply a bias forceopposing relative pivotal movement between the first and the secondstruts 12, 14 in a first of two opposite directions and aiding suchpivotal movement in a second of the opposite directions. Facilitatingthe bias force is a second attachment of the power unit 100 to theplatform 10, occurring between tab 26 and tab reception aperture 112. Atab reception aperture 112 is also located on each of opposing sides ofthe power unit 100 (i.e., on each housing side plate 106, 108).

In one embodiment, the tab 26 includes a shelf, or 90 degree lip (asbest shown in FIG. 2b ), creating a latch mechanism. The tab receptionaperture 112 includes, at an outer edge (near to the top) thereof, amovable (slidable) door 111 adapted to slide over the tab receptionaperture 112 and catch (latch) to the lip or shelf of the tab 26. Theslidable door 111 is operable from, and communicates with, a springbiased, slidably translatable sliding bar 113, which extends from acenter area of the power unit 100. Translating the sliding bar 113 awayfrom the center of the power unit 100 fully opens the tab receptionaperture 112 to receive the 90 degree angled tab 26. Releasing thesliding bar, via spring bias closing, returns the slidable door towardsthe center of the power unit 100 to catch the shelf portion of the tab26.

Thereafter, the power unit 100 can be detached from the platform 10, viasliding bar 113, flipped over and reattached to the platform 10, againvia the spline 18 and the reception slot 104 open on a second housingside plate 106 of the power unit 100, and via the tab 26, tab receptionaperture 112 and sliding bar 113. The power unit 100 will then apply abias force opposing relative pivotal movement between the first and thesecond struts 12, 14 in a second of two opposite directions and will aidsuch pivotal movement in a first of the opposite directions.

Referring now to FIG. 6, the power unit 100 further includes anexternally threaded spring band 114 located about a perimeter of thetorsion spring 102. The spring band 114 is fixedly attached (e.g. by pinand socket connector 116) to a second end 118 of the torsion spring 102.Further, a stationary, but axially rotatable, worm gear 120 is locatedabout a perimeter of the spring band 114. The worm gear 120 threadablycommunicates with the spring band 114 to preload the torsion spring 102.In one embodiment, the torsion spring 102, the spring band 114 and theworm gear 120 are positioned in the same plane (e.g., positioned in asimilar plane, perpendicular to a longitudinal axis of the receptionslot 104 (and thereby the spline 18, when the assembly is in operation).

In one embodiment of the invention, the platform 10 and torsion spring102 provide a 150 degree range of motion of the struts 12, 14. Thetorsion spring 102 operates over 402 degrees. The externally threadedspring band 114 includes threads over a portion of the externalperimeter. Through operation of the worm gear 120, the spring band 114provides torsion spring preload over seven (7) settings at 36 degreeincrements, for a total of 252 degrees. This 252 degree preloadcapability, plus the 150 degree operable range of motion, cover the 402degree range of the torsion spring 102 for this certain embodiment.Multiple variations and permutations are possible.

FIGS. 7a, 7b and 7c illustrate a front, a side and an exploded view,respectively, of another embodiment of the platform of the presentinvention (i.e., the platform 10 shown in FIG. 1). Much of the detaileddescription of the component parts and functionality of the FIG. 7platform embodiment is similar to the platform embodiment of FIGS. 2a,2b and 3. Note that the proximal and distal struts are shown in croppedformat (actual length can vary due to patient need). Table 1 provides aconvenient list/explanation of component parts of the FIGS. 7a, 7b and7c embodiment of the platform 10 of the present invention.

TABLE 1 An Embodiment of Platform 10 of the Present Invention (see FIGS.7a, 7b, 7c) Component No. Component Description 12 Proximal Strut -Platform 14 Distal Strut - Platform 18 Spline Driver Shaft - Platform 22Don/Doff Lock Slide - Platform 26 Power Unit Catch - Platform 28 Rangeof Motion (ROM) Wheel, or ROM Gear - Platform 30 ROM Worm Gear -Platform 34 ROM Worm Gear Housing, or ROM Worm Housing - Platform 35Platform Retainer - Platform 37 Catch Housing - Platform 38 Don/DoffHandle, or Lock Out Handle - Platform 42 Washer    42A Washer 43Compression Spring 44 Compression Spring 45 Dowel Pin 46 Screw - e.g.,Flat Head Phillips 47 Screw - e.g., Flat Head Phillips 48 Ball Bearing49 Grooved Pin 50 Bushing - Platform 52 Stop Angle Mark(s) (SAM) 53Power Unit Release Button 54 End Range Tapped Holes 55 End RangeScrew(s) 56 Arcuate Slot (retaining therein end range screws 55 insertedinto end range tapped holes 54)

FIGS. 8a, 8b, 8c, 8d and 8e illustrate a perspective, a top side, anedge, an opposite side, and an exploded view, respectively, of anotherembodiment of the power unit 100 of the present invention (i.e., thepower unit 100 shown in FIG. 1). Table 2 provides a convenientlist/explanation of component parts of the FIGS. 8a, 8b, 8c, 8d and 8eembodiment of the power unit 100 of the present invention. In Table 2,and in FIGS. 8a, 8b, 8c, 8d and 8e , CW stands for clockwise and CCW forcounter-clockwise.

TABLE 2 An Embodiment of Power Unit 100 of the Present Invention (seeFIGS. 8a, 8b, 8c, 8d, 8e) Component No. Component Description 101Washer-Spring Componentry 102 Torsion Spring - Power Unit 103 IndicatorPlate - CW Power Unit 104 Spline Pivot Shaft - Power Unit 106 HousingSide Plate, CCW - Power Unit 107 Indicator Plate, CCW Power Unit 108Housing Opposite Side Plate, CW, Power Unit 112 Catch Receiver (throughaperture with wall thickness) 114 Ring Gear, or Spring Band - Power Unit116 Screw (e.g., Flat Head Socket) 120 Worm, or Worm Gear - Power Unit121 Retaining Ring 122 Flat Washer 123 Grooved Pin 124 Tension LevelIndicator 126 Assist Direction Indicator 128 Tension Adjustor Location(using Worm Gear)

Using Embodiments of the Present Invention

Orthotic devices/braces that incorporate embodiments of the presentinvention are intended for therapeutic use to manage loss of motionassociated with various neurological and orthopedic indications for bothadults and pediatrics. Neurological indications include cerebral palsy,cerebral vascular accident, spina bifida, traumatic brain injury,brachial plexus injury, spinal cord injury, multiple sclerosis, andreflex sympathetic dystrophy. Orthopedic indications include ligamenttears, tendon rupture/repair, toe walking, burns, limb loss, rheumatoidarthritis, severe fractures/trauma, arthrogryposis, muscular dystrophy,and total knee arthoplasty. Contraindications include fixed deformities.

Two primary components of the present invention are the orthotic joint(platform) and the adjustable assist unit (power unit). Whenincorporated into an orthosis, the platform serves as an orthotic hingeor joint with features to statically control motion. The power unitmounts to the platform and provides continuous tension to a limb torestore range of motion to the affected joint.

FIGS. 9a, 9a ′ and 9 b illustrate a front profile, a side profile and areverse profile of the platform 10 embodiment of FIGS. 7a, 7b, and 7c .FIGS. 10a and 10b illustrate a front profile and a reverse profile ofthe power unit 100 embodiment of FIGS. 8a, 8b, 8c, 8d and 8e . Duringuse of embodiments of the present invention, FIGS. 9a, 9a ′, 9 b, 10 aand 10 b show that the following components of the platform and of thepower unit can at least be, and/or variously can at least provide:

-   -   Proximal Strut 12: aluminum upright bar contoured and fastened        to an orthotic shell proximal to the anatomical joint;    -   Lock Out Handle 38: blue-colored handle used to lock the        platform 10;    -   Power Unit Catch 26: spring loaded latch that inserts into a        catch receiver 112 of the power unit 100, serving to maintain        engagement between the platform 10 and the power unit 100;    -   Spline 18: centrally located grooved shaft that mates with the        spline receiver (reception slot) 104 of the power unit 100;    -   Range of Motion (ROM) Wheel or Gear 28: circular ridged gear        whose position can be adjusted to change extension or flexion        range of motion limits;    -   Stop Angle Mark 52: one of two red colored reference marks        located on the ROM wheel, used to gauge the angle to which the        ROM wheel 28 stops at a particular range of motion of the        platform 10;    -   Worm 30: a gear which, when turned, will change the position of        the ROM wheel 28 and stop angle mark(s) 52 to set a range of        motion stop for the platform 10;    -   Distal Strut 14: aluminum upright bar contoured and fastened to        an orthotic shell distal to the anatomical joint;    -   Power Unit Release Button 53: allows for the power unit 100 to        be detached from the platform 10 when pressed (linearly        translated) in a upward direction;    -   Platform Retainer 35: pivot point 16 and central fastener for        the platform 10; is also used with tool (jig), engaged thereon,        to facilitate proper alignment of orthotic joints to one        another;    -   End Range Tapped Holes 54: four tapped end range holes 54 (A, B,        C, D) are provided (as shown in FIG. 9b ) on a reverse profile        of the platform 10. Each end range tapped hole 54A, 54B, 54C,        54D, is designed to receive an end range screw 55 to set up the        platform 10 with a normal anatomical range of the respective        joint—intended to treat and to ensure proper functioning of the        power unit 100. The end range screw(s) 55 extend from respective        end range tapped hole(s) 54 into an arcuate slot 56 in a member        becoming the distal strut 14. One or two end range screw(s) 55        are usually used (e.g. in holes A and B; in hole C only; in hole        D only). Referring to FIG. 9b , two end range screws 55 (one in        each of holes A and B) are shipped pre-installed from factory.        End range screws 55 in only holes A and B are recommended for        ankle or wrist applications. An end range screw 55 in hole C is        recommended for right knee or left elbow applications. An end        range screw 55 in hole D (see FIG. 12e ) is recommended for left        knee or right elbow applications;    -   Catch Receiver 112: a through feature (aperture with wall        thickness) located on a proximal aspect of the power unit        100—designed to interface with the power unit catch 26;    -   Tension Level Indicator 124: indicates through housing window a        current tension setting of the power unit 100. Tension settings        can range from a minimum of 0 to a maximum of 7, in increments        of 0.5. An initial factory setting can be 1.    -   Spline Receiver (Reception Slot) 104: grooved (internally        threaded) feature that engages the spline 18 of the platform 10;    -   Assist Direction Indicator 126: markings on housing of power        unit (clockwise or counterclockwise) indicating a direction of        the assistance generated by the power unit 100; and    -   Tension Adjustor 128: mechanism used to increase/decrease        tension generated by the power unit 100.

Locking and unlocking the platform 10 (see FIGS. 9a and 9a ′). The lockout handle 38 is used to immobilize or “lock-out” the platform 10,primarily for donning and doffing the orthosis with the power unit 100attached and tensioned. In FIGS. 9a and 9a ′, the platform 10 is shownwithout the power unit 100 to better illustrate the mechanics of thelocking mechanism. To use the lock out handle 38, follow these steps:

-   -   to lock, press the lock out handle 38 downward, linearly        translating the lock out handle 38 along a longitudinal axis of        the proximal strut 12, until a toothed lock slide 22 (connected        at a distal end of the lock out handle 38) is fully engaged with        the toothed perimeter edge of the ROM wheel 28 (as shown in        FIGS. 9a and 9a ′); and    -   to unlock, pull the lock out handle upward (proximally),        linearly translating the lock out handle 38 along the        longitudinal axis of the proximal strut 12 away from the ROM        wheel 28, until the toothed lock slide 22 is fully disengaged        from the toothed perimeter of the ROM wheel 28 (as shown in FIG.        11a ).        An audible ‘snap’ will be heard when the lock out handle 38 is        successfully locked or unlocked.

In certain embodiments of the present invention, the platform 10 canprovide up to a 150° range of motion of the proximal and the distalstruts 12, 14. As detailed above, and referring to FIG. 9b , initialsetup for a left knee or right elbow can allow motion from 135° offlexion to 15° of hyperextension with an end range screw 55 insertedinto end range tapped hole 54D (see also FIG. 12e ). Initial setup for aright knee or left elbow can allow motion from 135° of flexion to 15° ofhyperextension with an end range screw 55 inserted into end range tappedhole 54C. For wrist or ankle applications, initial setup having endrange screws 55 inserted in each of end range tapped holes 54A and 54Ballows motion from 75° of plantar (palmar) flexion to 75° ofdorsiflexion. The end range screws 55 provide correct anatomical rangefor the joint to be treated.

FIGS. 11a, 11b and 11c illustrate how the platform 10 may be furtherfine-tuned to block excessive or unwanted flexion or extension, allowingfor infinite positioning options between the fixed limits established bythe end of range screw(s) 55 inserted into the end range tapped hole(s)54 (A, B, C, D) and engaging the arcuate slot 56. The ROM wheel 28includes two red colored stop angle marks (SAMs) 52 within the teeth ofthe ROM wheel 28. The stop angle marks 52 are most clearly visible froma side view of the platform (see FIGS. 9a and 9a ′). One SAM 52corresponds to extension range limitation and the other SAM 52 toflexion range limitation. The key to success with fine tuning theplatform's range of motion lies in understanding the relationshipbetween the SAMs 52 and the proximal strut 12. Specifically, theplatform's motion will stop at an angle where a SAM 52 intersects themidline of the proximal strut 12.

Note that platform 10 fine-tuning is provided to limit range of motionin either a flexion or extension direction—one cannot limit bothdirections simultaneously. Therefore, only one SAM 52 has significanceto platform range of motion. The illustrations of FIGS. 11a, 11b and 11c show fine-tuning with the power unit 100 detached from the platform 10(just to better illustrate the mechanics involved). However, theplatform's range of motion may be fine-tuned with or without the powerunit 100 attached.

To adjust the range of motion:

-   -   unlock the platform 10 (as detailed above);    -   the initial factory position of the platform 10 is shown in FIG.        11a . Note the position of the proximal and distal struts 12, 14        at a 180° relationship, and of the red stop angle marks (SAMs)        52 at the 5 and 7 o'clock positions. In the initial factory        position (at 5 and 7 o'clock; as shown in FIG. 11a ), the ROM        wheel 28 does not influence the range of motion of the platform        10;    -   the ROM wheel 28 position is adjusted by turning the worm 30        with a ball driver 200 (see FIGS. 11b and 11c ). The worm 30 may        be turned in either direction; and    -   starting at the initial factory position, depending on the        direction the worm 30 is turned, one of the SAMs 52 will move        into closer proximity to the proximal strut 12 compared to the        other SAM 52. The “closer” SAM 52 represents the stop point. The        platform 10 will not be moveable (rotatable) past the region        where the SAM 52 intersects the midline of the proximal strut        12—free range of motion will be available in the other        direction. FIGS. 11b and 11c illustrate two possible settings of        the ROM wheel 28. In FIG. 11b , range of motion of the proximal        strut 12 relative to the distal strut 14 is limited to        approximately 35° in the direction (arrow) indicated. In FIG.        11c , range of motion of the proximal strut 12 relative to the        distal strut 14 is limited to approximately 90° in the direction        (arrow) indicated.

FIGS. 12a, 12b, 12c, 12d and 12e illustrate how to set up the platform10 and attach the power unit 100 to the platform 10 for certainflexion/extension assist:

-   -   set the ROM wheel 28 to its initial factory position (as        detailed above);    -   move the distal strut 14 of the platform 14 to the maximum end        range of the direction to be assisted;        For example, to assist ankle dorsiflexion move the distal strut        14 to its maximally dorsiflexed position (+75° dorsiflexion). If        the platform 10 is not moved to the maximum end range of the        direction to be assisted, internal stops of the power unit 100        will limit the range of motion of the platform 10—thereby        diminishing assistance output of the power unit 100.    -   lock the platform 10 in the position of maximum end range of the        direction to be assisted. FIG. 12a shows the platform 10        oriented for right elbow extension assist (and/or left knee        extension assist). As shown in FIG. 12a , maximum extension end        range for an elbow setup is 15° of hyperextension;    -   orient the power unit 100 so the assist direction indicator 126        (on the side up, away from the platform upon attachment) shows        the direction (clockwise or counterclockwise) of the motion you        wish to assist. FIG. 12b shows the power unit 100 oriented to        assist right elbow extension (and/or left knee extension);    -   line up the spline 18 and the power unit catch 26 of the        platform 10 with the spline receiver (reception slot) 104 and        the catch receiver 112 of the power unit as shown in FIG. 12c .        Press the power unit 100 onto the platform 10. You should hear        the power unit 100 catch ‘click’ into place upon successful        latching of the power unit 100;    -   FIG. 12d shows a successfully attached power unit 100 to        platform 10 from a top profile view; FIG. 12e shows the same,        attached power unit 100 to platform 10 from a rear side profile        view (also showing one end range screw 55 inserted in an end        tapped hole 54 (specifically, end tapped hole 54D—see also FIG.        9b ) and extending into the arcuate slot 56); and    -   unlock the platform 10 and test the assembly, ensuring correct        range of motion. For an elbow or knee assembly (as detailed        above), the platform 10 should have range of motion from 135° of        flexion to 15° of hyperextension—ensure that resistance is felt        in correct direction

To remove the power unit 100 from the platform 10:

-   -   move the lock out handle 38 of the platform 10 to the unlocked        position (as detailed above);    -   for removal of the power unit 100 from the platform 10, the        platform 10 must again be at the end range of the assisted        direction. Using the lock out handle 38, lock the platform 10 in        this position; and    -   push the power unit release button 53 upward (proximally,        linearly away from the pivot point—see FIG. 9b ). While holding        the power unit release button 53 upward (against spring bias),        lift the power unit 100 off the platform 10.

The assist direction of the power unit 100 can be reversed to assist inthe opposite direction. For example, a power unit 100 oriented on aplatform 10 for knee extension assist could be reversed for knee flexionassist; a power unit 100 oriented on a platform 10 for wrist extensionassist could be reversed for wrist palmar flexion assist, etc. Toreverse the assist direction of the power unit 100 on the platform 10(for example, here, setting the power unit 100 for flexion assist of theright elbow:

-   -   remove the power unit 100 and set the ROM wheel 28 to its        initial factory position (as detailed above);    -   move the distal strut 14 into maximum flexion range (for a right        elbow or left knee −135°);    -   lock the platform 10 in this position (using lock out handle        38);    -   orient the power unit 100 so that the assist direction indicator        126 on the side facing up (i.e., away from the platform 10 upon        attachment) shows (points in) the direction (clockwise or        counterclockwise) you wish to assist (here, counterclockwise for        right elbow or left knee flexion force); and    -   attach the power unit 100 to the platform 10.

To adjust the tension of the power unit 100:

-   -   the power unit 100 can be adjusted for tension between a minimum        level of 0 and a maximum level of 7. In its initial factory        setting, the power unit 100 has tension set at level 1 (see        FIGS. 10a and 10b for tension adjuster location 138—operation of        worm 120);    -   the power unit 100 may be adjusted for tension on or off the        platform 10. Use the included Ball Driver 200 to turn the worm        120 (tension adjustor location 138) to increase/decrease the        tension of the power unit 100 (torsion spring 102). The tension        adjustor 138 can be approached (with the ball driver 200) from        either side of the worm 120. Depending on the side of the power        unit 100 (specifically, the worm 120) chosen to make the        adjustment, as well as the direction of the assist selected, the        tension adjustor 138 (worm 120) may require turning either        toward you or away from you (clockwise or counterclockwise) to        increase (decrease) the tension—watch tension level indicator        124.    -   to decrease the tension, simply turn the tension adjustor 138        (worm 120) in the opposite direction.

These and other advantages of the present invention will be apparent tothose skilled in the art from the foregoing specification. Accordingly,it will be recognized by those skilled in the art that changes ormodifications may be made to the above-described embodiments withoutdeparting from the broad inventive concepts of the invention. Forexample, features detailed as included in certain specific embodimentsabove are recognized as interchangeable and possibly included in otherdetailed embodiments. Specific dimensions of any particular embodimentare described for illustration purposes only. It should therefore beunderstood that this invention is not limited to the particularembodiments described herein, but is intended to include all changes andmodifications that are within the scope and spirit of the invention.

What is claimed is:
 1. A hinge assembly for an orthotic, prosthetic orrehabilitative device, comprising: a first strut and a second strutpivotally attached to one another at a pivot point; a spline extendingin a first direction perpendicularly from the first strut and the secondstrut, at the pivot point, the spline being rotatable relative to one ofthe first strut and the second strut, where the other of the first strutand the second strut has a catch extending in the first direction,located radially of the pivot point; and a torsion spring having a firstend and a second end; wherein the first end of the torsion springremovably communicates with the extending spline and the second end ofthe torsion spring removably communicates with the extending catch, thetorsion spring applying a bias force opposing relative pivotal movementbetween the first and the second struts in a first of two directions,and aiding pivotal movement in a second of the two directions; andwherein, when the torsion spring is removed from the extending splineand from the extending catch, the torsion spring is flipped over, andthe first end of the torsion spring removably communicates with theextending spline, and the second end of the torsion spring removablycommunicates with the extending catch, the torsion spring applies a biasforce opposing relative pivotal movement between the first and thesecond struts in the second direction, and aids pivotal movement in thefirst direction.
 2. The hinge assembly of claim 1, wherein the torsionspring is a circular leaf spring and is enclosed by a housing.
 3. Thehinge assembly of claim 1, further comprising: a toothed tension wheelmounted about the pivot point and being rotatably fixed relative to thespline; and a worm gear located about a perimeter of the tension wheel,the worm gear threadably communicating with the tension wheel to preloadthe torsion spring.
 4. The hinge assembly of claim 1, furthercomprising: a toothed range of motion wheel mounted about the pivotpoint and being rotatably fixed relative to one of the first strut andthe second strut; and a toothed disk, aligned with and linearlytranslatable relative to the other of the first strut and the secondstrut, the toothed disk threadably communicating with the toothed rangeof motion wheel to arrest pivotal movement between the first and thesecond struts.
 5. The hinge assembly of claim 4, wherein the torsionspring, the toothed range of motion wheel, and the toothed disk arepositioned in one or more parallel planes, the one or more parallelplanes being perpendicular to a longitudinal axis of the spline.
 6. Thehinge assembly of claim 1, further comprising: at least one end rangetapped hole within, and rotatably fixed relative to, one of the firstand the second struts; at least one end range screw, inserted into andextending from the at least one end range tapped hole; wherein theextending at least one end range screw abuts the other of the first andthe second struts to limit pivotal range of motion between the first andthe second struts.
 7. The hinge assembly of claim 6, wherein the atleast one end range screw, inserted into and extending from the at leastone end range tapped hole provides up to a 150° range of motion of thefirst and the second struts.
 8. The hinge assembly of claim 6, furthercomprising at least a second end range tapped hole, and at least asecond end range screw, wherein the end range tapped holes have aposition, where, with respective end range screws inserted therein,allow motion of the first and the second struts from 135° of flexion to15° of hyperextension, thereby providing correct anatomical range ofmotion for a knee.
 9. The hinge assembly of claim 6, further comprisingat least a second end range tapped hole, and at least a second end rangescrew, wherein the end range tapped holes have a position, where, withrespective end range screws inserted therein, allow motion of the firstand the second struts from 75° of plantar flexion to 75° ofdorsiflexion, thereby providing correct anatomical range of motion for awrist or ankle.
 10. The hinge assembly of claim 6, wherein the at leastone end range screw extends from the at least one end range tapped holein a direction parallel to a longitudinal axis of the spline.
 11. Thehinge assembly of claim 1, further comprising: a platform, where thefirst strut and the second strut form at least a portion thereof; theplatform further including a joint assembly comprising the pivot pointand the spline, where the spline is threaded and is workably fixed toone of the first strut or the second strut, the other of the first strutand the second strut having the catch located thereon; and a power unitincluding: the torsion spring; and a housing around and enclosing thetorsion spring, the housing having an internally threaded reception slotcentrally located on each side thereof, the reception slot workablycommunicating with the first end of the torsion spring, removablyconnecting the first end of the torsion spring to the threaded spline,the housing further having a catch receiver located on each sidethereof, the catch receiver workably communicating with the second endof the torsion spring, removably connecting the second end of thetorsion spring to the extending catch; wherein, with a first housingside exposed away from the platform, the power unit attaches to theplatform to apply a bias force opposing relative pivotal movementbetween the first and the second struts in a first of two directions,and aiding pivotal movement in a second of the two directions; andwherein, with a second housing side exposed away from the platform, thepower unit attaches to the platform to apply a bias force opposingrelative pivotal movement between the first and the second struts in thesecond direction, and aiding pivotal movement in the first direction.12. The hinge assembly of claim 11, wherein the power unit is detachedfrom the platform, flipped over, and is reattached to the platform,without the use of tools, from the first housing side being exposed awayfrom the platform to the second housing side being exposed away from theplatform.
 13. The hinge assembly of claim 11, wherein points ofattachment between the power unit and the platform consist only of theone central reception slot located on each side of the housing, thethreaded spline, the catch receiver located on each side of the housing,and the extending catch.
 14. The hinge assembly of claim 11, wherein theplatform further comprises an axially translatable handle with tootheddisk that toothedly engages a gear centered about the pivot point toarrest pivotal movement of the first strut relative to the second strut.15. A hinge assembly for an orthotic, prosthetic or rehabilitativedevice, comprising: a first strut and a second strut pivotally attachedto one another at a pivot point; a spline extending in a first directionperpendicularly from the first strut and the second strut, at the pivotpoint, the spline being rotatable relative to one of the first strut andthe second strut, where the other of the first strut and the secondstrut has a catch extending in the first direction, located radially ofthe pivot point; a torsion spring having a first end and a second end; atoothed range of motion wheel mounted about the pivot point and beingrotatably fixed relative to one of the first strut and the second strut;a toothed disk, aligned with and linearly translatable relative to theother of the first strut and the second strut, the toothed diskthreadably communicating with the toothed range of motion wheel toarrest pivotal movement between the first and the second struts; atoothed tension wheel mounted about the pivot point and being rotatablyfixed relative to the spline; a worm gear located about a perimeter ofthe toothed tension wheel, the worm gear threadably communicating withthe tension wheel to preload the torsion spring; at least one end rangetapped hole within, and rotatably fixed relative to, one of the firstand the second struts; at least one end range screw, inserted into andextending from the at least one end range tapped hole, where theextending at least one end range screw abuts the other of the firststrut and the second strut to limit pivotal range of motion between thefirst and the second struts; wherein the first end of the torsion springremovably communicates with the extending spline and the second end ofthe torsion spring removably communicates with the extending catch, thetorsion spring applying a bias force opposing relative pivotal movementbetween the first and the second struts in a first of two directions,and aiding pivotal movement in a second of the two directions; andwherein, when the torsion spring is removed from the extending splineand from the extending catch, the torsion spring is flipped over, andthe first end of the torsion spring removably communicates with theextending spline, and the second end of the torsion spring removablycommunicates with the extending catch, the torsion spring applies a biasforce opposing relative pivotal movement between the first and thesecond struts in the second direction, and aids pivotal movement in thefirst direction.
 16. The hinge assembly of claim 15, wherein the torsionspring is a circular leaf spring and is enclosed by a housing, andwherein the torsion spring, the toothed range of motion wheel, and thetoothed disk are positioned in one or more parallel planes, the one ormore parallel planes being perpendicular to a longitudinal axis of thespline.
 17. The hinge assembly of claim 15, further comprising at leasta second end range tapped hole, and at least a second end range screw,wherein the end range tapped holes have a position, where, withrespective end range screws inserted therein, allow motion of the firstand the second struts from 135° of flexion to 15° of hyperextension,thereby providing correct anatomical range of motion for a knee.
 18. Thehinge assembly of claim 15, further comprising at least a second endrange tapped hole, and at least a second end range screw, wherein theend range tapped holes have a position, where, with respective end rangescrews inserted therein, allow motion of the first and the second strutsfrom 75° of plantar flexion to 75° of dorsiflexion, thereby providingcorrect anatomical range of motion for a wrist or ankle.
 19. A method ofreversing an angular direction of force applied by a hinge assembly foran orthotic, prosthetic or rehabilitative device, where the hingeassembly comprises: a first strut and a second strut pivotally attachedto one another at a pivot point; a spline extending in a first directionperpendicularly from the first strut and the second strut, at the pivotpoint, the spline being rotatable relative to one of the first strut andthe second strut, where the other of the first strut and the secondstrut has a catch extending in the first direction, located radially ofthe pivot point; and a torsion spring having a first end and a secondend; the method comprising the steps of: attaching the first end of thetorsion spring to the extending spline, and attaching the second end ofthe torsion spring to the extending catch, wherein the torsion springapplies a bias force opposing relative pivotal movement between thefirst and the second struts in a first of two directions, and aidspivotal movement in a second of the two directions; removing the firstend of the torsion spring from the extending spline, and removing thesecond end of the torsion spring from the extending catch; flipping thetorsion spring over; and attaching the first end of the torsion springto the extending spline, and attaching the second end of the torsionspring to the extending catch, wherein the torsion spring applies a biasforce opposing relative pivotal movement between the first and thesecond struts in the second direction, and aids pivotal movement in thefirst direction.
 20. The method of claim 19, wherein the hinge assemblyfurther comprises: a toothed range of motion wheel mounted about thepivot point and being rotatably fixed relative to one of the first strutand the second strut; and a toothed disk, aligned with and linearlytranslatable relative to the other of the first strut and the secondstrut, the toothed disk threadably communicating with the toothed rangeof motion wheel to arrest pivotal movement between the first and thesecond struts; a toothed tension wheel mounted about the pivot point andbeing rotatably fixed relative to the spline; a worm gear located abouta perimeter of the toothed tension wheel, the worm gear threadablycommunicating with the tension wheel to preload the torsion spring; atleast one end range tapped hole within, and rotatably fixed relative to,one of the first and the second struts; and at least one end rangescrew, inserted into and extending from the at least one end rangetapped hole, where the extending at least one end range screw abuts theother of the first strut and the second strut to limit pivotal range ofmotion between the first and the second struts.